Cleared Traditional

TRAJECTORY GUIDE, MODEL # TGX-XXX (K983539) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983539 · Image-Guided Neurologics, Inc. · Neurology device
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Feb 1999
Decision
126d
Days
Class 2
Risk

K983539 is an FDA 510(k) clearance for the TRAJECTORY GUIDE, MODEL # TGX-XXX. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Oakdale, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Image-Guided Neurologics, Inc. devices

Submission Details

510(k) Number K983539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date February 12, 1999
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 104
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K983539.
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999
VIEWPOINT MICROSCOPE OPTION
K990860 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · Philips Medical Systems (Cleveland), Inc. · Jan 1997
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990